Mike Moran

I once hosted a webinar on the use of social media in the financial services industry. Regulated industries (such as financial services and pharmaceuticals) tend to have their own unique concerns when they embark on social media listening. While some pharmaceutical companies are willing to dive right in, others have held back, concerned about the requirement to report all "adverse events" from medications. What do the listening companies know that the sidelined companies don't?

First off, I don't want to minimize the regulatory concerns of pharmaceutical companies. It is indeed true that they have a duty to report to the FDA any reports they become aware of that one of their drugs has produced an adverse event in a patient. Typically, they become aware of such incidents when the patient calls them to report a problem, and they have well-worn processes to collect the information and make the proper report to authorities.

But what do they do in social media? How do they report that @patient tweeted that she felt dizzy after taking brand-name-drug? Some companies believed that they could protect themselves from liability by intentionally NOT listening to such chatter. If they are not aware of the report, then they are under no compunction to report it. It's logical from a legal point of view, but does it make sense? I mean, the same lawyers could just as easily disconnect the phones to call centers to remove the risk of hearing of adverse events by phone.

Clearly, pharmaceutical companies must do more. The leading companies are taking the same approach in social media that they do for any other contact with patients, but it takes some thinking. When a patient phones you to ask a question or report a symptom, the company can make sure that all of the questions are answered so that a complete report can be filed. In social media, that's not so easy.

One study shows that 0.3% of social media conversations contained any report of adverse effects from brand name drugs, and that, of those, only 14% contain enough information to file an official report with the FDA. So, the companies were not required to file reports in the rest of those cases. What's more, because the companies have all the processes in place to file reports from other sources of information, all that was needed was a mechanism that identifies those events and triggers the existing reporting function. This triggering mechanism is not unlike the training that phone reps get as to when they should be asking questions on the phone to file a report.

As with most things in social media, problems that start out seeming big usually turn out to just take a bit of extra thinking. Now, the FDA might at some point change its regulations and impose even more requirements on what is expected of companies in social media. Perhaps companies will be required to have listening programs. Maybe the government will even go so far as to require companies to reach out in dialogue to gather more information from the 86% of people who report adverse events without meeting the reporting requirement, just as they expect a phone caller to be asked enough questions to file an adverse event report. If that happens, the companies who have already taken steps in social media listening will be ahead of the game.

But even if the regulations do not change, the vast majority of conversation about pharmaceuticals is NOT about adverse events, so companies ignoring this conversation are missing a wealth of information that could help them make better business decisions today.

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